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Last Updated: April 25, 2024

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DOVATO Drug Patent Profile


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When do Dovato patents expire, and when can generic versions of Dovato launch?

Dovato is a drug marketed by Viiv Hlthcare and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and eighty patent family members in forty-nine countries.

The generic ingredient in DOVATO is dolutegravir sodium; lamivudine. There are seventeen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the dolutegravir sodium; lamivudine profile page.

DrugPatentWatch® Generic Entry Outlook for Dovato

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 24, 2031. This may change due to patent challenges or generic licensing.

There have been twenty patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for DOVATO
Drug Prices for DOVATO

See drug prices for DOVATO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DOVATO
Generic Entry Date for DOVATO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DOVATO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
ViiV HealthcarePhase 1
Saint Michael's Medical CenterPhase 4
Societa' Italiana Di Malattie Infettive E TropicaliPhase 3

See all DOVATO clinical trials

Paragraph IV (Patent) Challenges for DOVATO
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DOVATO Tablets dolutegravir sodium; lamivudine 50 mg/300 mg 211994 1 2019-07-30

US Patents and Regulatory Information for DOVATO

DOVATO is protected by three US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of DOVATO is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting DOVATO

Antiviral therapy
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HIV INFECTION

Substituted 5-hydroxy-3,4,6,9,9a, 10-hexanhydro-2h-1-oxa04a,8a-diaza-anthracene-6,10-dioness
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Synthesis of carbamoylpyridone HIV integrase inhibitors and intermediates
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Viiv Hlthcare DOVATO dolutegravir sodium; lamivudine TABLET;ORAL 211994-001 Apr 8, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for DOVATO

When does loss-of-exclusivity occur for DOVATO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 51
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 11209788
Estimated Expiration: ⤷  Try a Trial

Patent: 14202404
Estimated Expiration: ⤷  Try a Trial

Patent: 14202405
Estimated Expiration: ⤷  Try a Trial

Patent: 14202406
Estimated Expiration: ⤷  Try a Trial

Patent: 16204987
Estimated Expiration: ⤷  Try a Trial

Patent: 17268621
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 2012018670
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 87691
Estimated Expiration: ⤷  Try a Trial

Patent: 67453
Estimated Expiration: ⤷  Try a Trial

Patent: 03988
Estimated Expiration: ⤷  Try a Trial

Patent: 60290
Estimated Expiration: ⤷  Try a Trial

Chile

Patent: 12002080
Estimated Expiration: ⤷  Try a Trial

China

Patent: 2791129
Estimated Expiration: ⤷  Try a Trial

Patent: 5311033
Estimated Expiration: ⤷  Try a Trial

Colombia

Patent: 02152
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 120423
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0150770
Estimated Expiration: ⤷  Try a Trial

Patent: 0180855
Estimated Expiration: ⤷  Try a Trial

Patent: 0181531
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 16509
Estimated Expiration: ⤷  Try a Trial

Patent: 20457
Estimated Expiration: ⤷  Try a Trial

Patent: 21040
Estimated Expiration: ⤷  Try a Trial

Patent: 18029
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 31027
Estimated Expiration: ⤷  Try a Trial

Patent: 32970
Estimated Expiration: ⤷  Try a Trial

Patent: 27542
Estimated Expiration: ⤷  Try a Trial

Patent: 94972
Estimated Expiration: ⤷  Try a Trial

Dominican Republic

Patent: 012000205
Estimated Expiration: ⤷  Try a Trial

Patent: 021000147
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 12012106
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 5176
Estimated Expiration: ⤷  Try a Trial

Patent: 2868
Estimated Expiration: ⤷  Try a Trial

Patent: 7601
Estimated Expiration: ⤷  Try a Trial

Patent: 1290583
Estimated Expiration: ⤷  Try a Trial

Patent: 1690872
Estimated Expiration: ⤷  Try a Trial

Patent: 1892277
Estimated Expiration: ⤷  Try a Trial

Patent: 2190473
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 31027
Estimated Expiration: ⤷  Try a Trial

Patent: 32970
Estimated Expiration: ⤷  Try a Trial

Patent: 27542
Estimated Expiration: ⤷  Try a Trial

Patent: 51249
Estimated Expiration: ⤷  Try a Trial

Patent: 94972
Estimated Expiration: ⤷  Try a Trial

Patent: 16599
Estimated Expiration: ⤷  Try a Trial

Finland

Patent: 94972
Estimated Expiration: ⤷  Try a Trial

France

Patent: C1043
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 79522
Estimated Expiration: ⤷  Try a Trial

Patent: 09629
Estimated Expiration: ⤷  Try a Trial

Patent: 50335
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 26849
Estimated Expiration: ⤷  Try a Trial

Patent: 37812
Estimated Expiration: ⤷  Try a Trial

Patent: 40554
Estimated Expiration: ⤷  Try a Trial

Patent: 800042
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 1007
Estimated Expiration: ⤷  Try a Trial

Patent: 5182
Estimated Expiration: ⤷  Try a Trial

Patent: 7267
Estimated Expiration: ⤷  Try a Trial

Patent: 7658
Estimated Expiration: ⤷  Try a Trial

Patent: 1959
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 68386
Estimated Expiration: ⤷  Try a Trial

Patent: 13518107
Estimated Expiration: ⤷  Try a Trial

Patent: 16145204
Estimated Expiration: ⤷  Try a Trial

Patent: 17008087
Estimated Expiration: ⤷  Try a Trial

Patent: 18127473
Estimated Expiration: ⤷  Try a Trial

Patent: 19167371
Estimated Expiration: ⤷  Try a Trial

Patent: 21091705
Estimated Expiration: ⤷  Try a Trial

Patent: 22071126
Estimated Expiration: ⤷  Try a Trial

Patent: 23085431
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 932970
Estimated Expiration: ⤷  Try a Trial

Patent: 2018013
Estimated Expiration: ⤷  Try a Trial

Patent: 32970
Estimated Expiration: ⤷  Try a Trial

Patent: 27542
Estimated Expiration: ⤷  Try a Trial

Patent: 94972
Estimated Expiration: ⤷  Try a Trial

Luxembourg

Patent: 0090
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 8334
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 6891
Estimated Expiration: ⤷  Try a Trial

Patent: 7937
Estimated Expiration: ⤷  Try a Trial

Patent: 7938
Estimated Expiration: ⤷  Try a Trial

Patent: 12008774
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 182
Estimated Expiration: ⤷  Try a Trial

Patent: 058
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 002
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 1319
Estimated Expiration: ⤷  Try a Trial

Patent: 7824
Estimated Expiration: ⤷  Try a Trial

Patent: 7826
Estimated Expiration: ⤷  Try a Trial

Patent: 7827
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 18036
Estimated Expiration: ⤷  Try a Trial

Patent: 32970
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 121524
Estimated Expiration: ⤷  Try a Trial

Patent: 160180
Estimated Expiration: ⤷  Try a Trial

Philippines

Patent: 016500195
Estimated Expiration: ⤷  Try a Trial

Patent: 018502489
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 31027
Estimated Expiration: ⤷  Try a Trial

Patent: 32970
Estimated Expiration: ⤷  Try a Trial

Patent: 27542
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 31027
Estimated Expiration: ⤷  Try a Trial

Patent: 32970
Estimated Expiration: ⤷  Try a Trial

Patent: 27542
Estimated Expiration: ⤷  Try a Trial

Patent: 94972
Estimated Expiration: ⤷  Try a Trial

San Marino

Patent: 01500177
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 123
Estimated Expiration: ⤷  Try a Trial

Patent: 323
Estimated Expiration: ⤷  Try a Trial

Patent: 728
Estimated Expiration: ⤷  Try a Trial

Patent: 183
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 2614
Estimated Expiration: ⤷  Try a Trial

Patent: 201509476R
Estimated Expiration: ⤷  Try a Trial

Patent: 201707183T
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 31027
Estimated Expiration: ⤷  Try a Trial

Patent: 32970
Estimated Expiration: ⤷  Try a Trial

Patent: 27542
Estimated Expiration: ⤷  Try a Trial

Patent: 94972
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 1205586
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1830715
Estimated Expiration: ⤷  Try a Trial

Patent: 1883750
Estimated Expiration: ⤷  Try a Trial

Patent: 1964923
Estimated Expiration: ⤷  Try a Trial

Patent: 120128640
Estimated Expiration: ⤷  Try a Trial

Patent: 160111536
Estimated Expiration: ⤷  Try a Trial

Patent: 170078868
Estimated Expiration: ⤷  Try a Trial

Patent: 180078358
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 43066
Estimated Expiration: ⤷  Try a Trial

Patent: 70811
Estimated Expiration: ⤷  Try a Trial

Patent: 88925
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 12000376
Estimated Expiration: ⤷  Try a Trial

Turkey

Patent: 1807704
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 5556
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering DOVATO around the world.

Country Patent Number Title Estimated Expiration
South Korea 101504998 ⤷  Try a Trial
Norway 2023042 ⤷  Try a Trial
Eurasian Patent Organization 032868 КОМБИНАЦИЯ ДЛЯ ЛЕЧЕНИЯ ВИЧ-ИНФЕКЦИИ (COMBINATION FOR TREATING HIV INFECTION) ⤷  Try a Trial
Israel 225207 נגזרת של קרבאמוילפירידון רב-טבעתי, הרכב רוקחי המכיל אותה, השימוש בה ותהליך להכנתה (Polycyclic carbamoylpyridone derivative, pharmaceutical composition comprising the same, use and process for preparation thereof) ⤷  Try a Trial
Canada 3003988 COMBINAISONS A UTILISER POUR L'INHIBITION DU VIH-1 (COMBINATIONS FOR USE IN THE INHIBITION OF HIV-1) ⤷  Try a Trial
European Patent Office 2527007 Dérivé de carbamoylpyridone polycyclique doté d'une activité inhibitrice de l'intégrase du VIH (Polycyclic carbamoylpyridone derivative having HIV integrase inhibitory activity) ⤷  Try a Trial
Slovenia 3045206 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for DOVATO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2465580 PA2021512,C2465580 Lithuania ⤷  Try a Trial PRODUCT NAME: KABOTEGRAVIRAS; REGISTRATION NO/DATE: EU/1/20/1481 20201217
2932970 2018C/041 Belgium ⤷  Try a Trial PRODUCT NAME: EEN COMBINATIE OMVATTENDE DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN (BIJVOORBEELD DOLUTEGRAVIRNATRIUM) EN RILPIVIRINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN (BIJVOORBEELD RILPIVIRINEHYDROCHLORIDE); AUTHORISATION NUMBER AND DATE: EU/1/18/1282 20180518
2932970 CA 2018 00036 Denmark ⤷  Try a Trial PRODUCT NAME: KOMBINATION OMFATTENDE DOLUTEGRAVIR ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. DOLUTEGRAVIRNATRIUM, OG RILPIVIRIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, F.EKS. RILPIVIRINHYDROCHLORID; REG. NO/DATE: EU/1/18/1282/001-002 20180518
1874117 300676 Netherlands ⤷  Try a Trial PRODUCT NAME: DOLUTEGRAVIR OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT OF SOLVAAT DAARVAN, MET INBEGRIP VAN DOLUTEGRAVIR NATRIUM; REGISTRATION NO/DATE: EU/1/13/892 20140121
2465580 17/2021 Austria ⤷  Try a Trial PRODUCT NAME: CABOTEGRAVIR UND SALZE DAVON; REGISTRATION NO/DATE: EU/1/20/1481 (MITTEILUNG) 20201221
1874117 C20140020 00130 Estonia ⤷  Try a Trial PRODUCT NAME: DOLUTEGRAVIIR;REG NO/DATE: K(2014)305 (LOPLIK) 21.01.2014
2465580 122021000021 Germany ⤷  Try a Trial PRODUCT NAME: CABOTEGRAVIR ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ ODER SOLVAT DAVON; REGISTRATION NO/DATE: EU/1/20/1481 20201217
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.